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Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

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ClinicalTrials.gov Identifier: NCT03769779
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Kemin Foods LC

Brief Summary:
Therefore, the present study is designed to contribute to the body of literature by investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin health and appearance in healthy women.

Condition or disease Intervention/treatment Phase
Aging Wrinkle Skin Elasticity Healthy Hydration Dietary Supplement: FloraGLO Lutein Dietary Supplement: Safflower Oil Not Applicable

Detailed Description:

This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the performance of an oral test product to evaluate the effects of twelve weeks of lutein supplementation on skin health and appearance in healthy women. A seven-day washout period will precede the evaluation period. The subjects in each cohort will use consume one softgel of their assigned test product (treatment or placebo) daily in the morning with breakfast for 12 weeks. Changes in skin condition and appearance as well as blood chemistry will be assessed using results from expert visual grading, instrumental assessments, skin and blood assays and subjective questionnaire responses. Subjects will be recruited during the winter season to account for seasonal variations of skin parameters.

Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes:

1. Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles 3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert clinical grading and subjective questionnaire responses.

6. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled, Parallel Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Envelopes that contain information regarding the coding of treatment and placebo will be provided to Sponsor, Site, and PI and kept in a secure location. Envelopes will be readily available for the investigator or site to open in the event that it becomes necessary to know which product a participant is taking for the sake of the participant health care. The sponsor must be notified of any unblinding by the site within 24 hours.
Primary Purpose: Prevention
Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arm Intervention/treatment
Experimental: Treatment
Lutein (FloraGLO™) in safflower oil
Dietary Supplement: FloraGLO Lutein
Lutein (FloraGLO™) in safflower oil

Placebo Comparator: Placebo
safflower oil
Dietary Supplement: Safflower Oil
Safflower Oil




Primary Outcome Measures :
  1. Objective Skin Hydration [ Time Frame: ANOVA including weeks 6 and 12 ]
    Corneometer Value

  2. Subjective Skin Hydration [ Time Frame: ANOVA including weeks 6 and 12 ]
    Subjective Questionnaire Visual Analog Scale


Secondary Outcome Measures :
  1. Objective Skin Texture [ Time Frame: ANOVA including weeks 6 and 12 ]
    Expert clinical grading

  2. Subjective Skin Texture [ Time Frame: ANOVA including weeks 6 and 12 ]
    Subjective Questionnaire Visual Analog Scale

  3. Objective Facial Lines and Wrinkles [ Time Frame: ANOVA including weeks 6 and 12 ]
    Expert clinical grading

  4. Subjective Facial Lines and Wrinkles [ Time Frame: ANOVA including weeks 6 and 12 ]
    Subjective Questionnaire Visual Analog Scale

  5. Objective Sagging skin, dry skin, skin tone, and overall appearance [ Time Frame: ANOVA including weeks 6 and 12 ]
    Expert clinical grading

  6. Subjective Sagging skin, dry skin, skin tone, and overall appearance [ Time Frame: ANOVA including weeks 6 and 12 ]
    Subjective Questionnaire Visual Analog Scale

  7. Objective Skin elasticity [ Time Frame: ANOVA including weeks 6 and 12 ]
    Expert clinical grading

  8. Subjective Skin elasticity [ Time Frame: ANOVA including weeks 6 and 12 ]
    Subjective Questionnaire Visual Analog Scale

  9. Skin Collagen Ultrasound [ Time Frame: ANOVA including weeks 6 and 12 ]
    Ultrasound

  10. Skin Collagen SIAsScope [ Time Frame: ANOVA including weeks 6 and 12 ]
    SIAsScope assessments

  11. Skin Lipids [ Time Frame: ANOVA including weeks 6 and 12 ]
    HPLC of tape strips

  12. Skin Carotenoids [ Time Frame: ANOVA including weeks 6 and 12 ]
    Total carotenoid concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Females in good health, and between the ages of 30 and 65 years old
  2. Fitzpatrick Skin Type I-V
  3. Mild to moderate loss of skin elasticity, wrinkles (global) and rough skin texture
  4. Able to read, understand and sign an informed consent form
  5. Willing and able to follow all study directions, attend study visits as scheduled and willing to accept the restrictions of the study
  6. Willing and able to maintain regular diet, exercise, hydration, and sleep patterns throughout the study

Exclusion Criteria:

  1. Participating in any other clinical study
  2. Acute or chronic disease or medical condition
  3. Unreliable or unlikely to be available for the duration of the study
  4. Routine use of tanning bed(s)
  5. History of abnormal response to sunshine
  6. Current usage of medications with contraindication of enhancing sun exposure, or medications for skin conditions.
  7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
  8. Immunocompromised subjects
  9. Subject has a history of unconventional sleep patterns
  10. Started Hormone Replacement Therapy within the last three months
  11. Using oral contraception for less than three months
  12. Known to be pregnant, lactating or planning to become pregnant within six months
  13. Unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769779


Contacts
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Contact: Stephen R Schwartz 914.937.6500 sschwartz@irsi.org

Locations
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United States, New York
International Research Services, Inc. Recruiting
Port Chester, New York, United States, 10573
Contact: Stephen R Schwartz    914-937-6500    sschwartz@irsi.org   
Sponsors and Collaborators
Kemin Foods LC

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Responsible Party: Kemin Foods LC
ClinicalTrials.gov Identifier: NCT03769779     History of Changes
Other Study ID Numbers: 4251KM0918
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No